Kornimate/medical-research-clean huggingface dataset:
compliance with clinical guidelines and effect on patient outcome of treatment of hospitalised exacerbations of copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: rationale. currently there are well-established guidelines for the management of stable copd. however, recommendations on the treatment of copd exacerbations (e-copd) are based on observational studies and low-quality clinical trials. in addition, there are some controversial aspects, such as treatment with systemic steroids. on the other hand, the available information on the adherence to the recommendations of the clinical practice guidelines (cpg) and its impact on the outcome of patients is scarce. main objectives. (1) to examine the appropriateness of two clinical guidelines (gold and gesepoc) of the current management of hospitalized exacerbations of copd; (2) to determine in real-life clinical practice the impact of adherence to cpg recommendations for management of copd exacerbations as an outcome of the disease (stay, in-hospital mortality, and 90-days post-discharge readmissions and mortality); (3) to examine the appropriateness of two clinical guidelines (gold and gesepoc) of the treatment of stable copd at admission and after discharge in patients hospitalized with exacerbated copd; (4) to determinate in real-life clinical practice the impact of the suitability to cpg recommendations for treatment of stable copd on 90-day post-discharge mortality and readmission of copd. method. national, multicenter, observational and longitudinal study of the first consecutive 20 patients hospitalized for exacerbations of copd between december 10 and 23, 2019 in the internal medicine services of the participating centers. patients will be followed 90 days after discharge. a total of 400 patients will be recruited in 20 spanish hospitals (20 per center). independent variables: age, sex, admission service, body mass index, dyspnea (mmrc), obstruction (fev¬₁), exacerbations in the previous year, comorbidities, bronchodilator treatment prior to admission, criteria of adequacy to the cpg in the clinical evaluation and treatment, hyperglycemia during the first 24 hours of admission, treatment of hyperglycemia and bronchodilator treatment at discharge. outcomes: in-hospital mortality, mortality at 90 days, re-admission at 90 days. statistical analysis: parametric and non-parametric tests, kaplan-meier and roc curves and multiple logistic regression.


Eligibility criteria:
inclusion criteria: * age over 40 years. * copd patient hospitalized with the main diagnosis of exacerbation of copd and whose main diagnosis is confirmed by the discharge report and the local investigator. exclusion criteria: * terminal disease * absence of spirometry confirmation of the copd diagnosis. * presence of other diseases that can cause symptoms like those of a copd exacerbation (e.g. heart failure, pneumonia, etc.), where exacerbation of copd is not the main cause of admission.

Keywords: chronic obstructive pulmonary disease acute exacerbation inpatients clinical practice guidelines bronchodilators compliance
gene testing to help in the diagnosis and treatment of childhood brain tumors

Conditions: Brain Tumors; Central Nervous System Tumors

Summary: rationale: analyzing the number and structure of genes found in a child's cancer cells may help doctors improve methods of diagnosing and treating children with brain tumors. purpose: this clinical trial is studying the number and structure of genes in cancer cells of children with brain tumors.

objectives: * determine the chromosomal gains and losses by dna ploidy analysis and comparative genomic hybridization in patients with primitive neuroectodermal tumors or medulloblastomas. * determine the frequency of specific chromosomal abnormalities, including deletions of chromosomal regions 6, 17, and 22, in these patients. * perform a statistical analysis to determine possible associations of chromosomal abnormalities and dna ploidy with patient age, tumor histology, tumor location, extent of disease, and event-free survival. outline: dna ploidy analysis will be performed to determine the overall level of aneuploidy. the results are compared to the comparative genomic hybridization (cgh) analysis, which is used to demonstrate tumor-specific losses or gains, including amplification, of specific chromosomal regions. tumors are also screened for specific abnormalities by fluorescent in situ hybridization (fish), which detects chromosomal rearrangements, including balanced translocations, deletions, amplifications, etc. pcr-based microsatellite polymorphism analysis may also be performed. primitive neuroectodermal tumors (pnets) are screened by fish with a distal 17p13.3 cosmid and a 17q25 cosmid to identify tumors with a 17p deletion. atypical teratoid/rhabdoid tumors and pnets without a 17p deletion are screened by fish with a series of cosmids from 22q11.2. pnets are also screened by interphase fish with cosmids from chromosome 6 to identify tumors with deletions. patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. projected accrual: this study will accrue 360 specimens.

Eligibility criteria:
disease characteristics: * histologically confirmed primary cns malignancy consistent with primitive neuroectodermal tumor, medulloblastoma, or atypical teratoid/rhabdoid tumor * must be entered on ccg-9921, ccg-9931, ccg-a9961, ccg-99703 or other front-line studies developed from ccg-90024 or ccg-90025 * retrospective specimens also obtained from ccg-921, ccg-923, ccg-9892, ccg-9921, and ccg-9931 patient characteristics: age: * under 21 performance status: * see disease characteristics life expectancy: * see disease characteristics hematopoietic: * see disease characteristics hepatic: * see disease characteristics renal: * see disease characteristics prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy * not specified radiotherapy * no prior radiotherapy surgery * not specified

Keywords: untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood medulloblastoma
the use of high concentration hyaluronic acid (ha) transfer medium in repeated implantation failure (rif) patients

Conditions: IVF; Embryo Loss; Miscarriage, Recurrent

Summary: this is a pilot study with the aim to investigate the beneficial effect of bicarbonate buffered medium containing hyaluronan and recombinant human albumin (embryoglue®, vitrolife) in patients with documented repeated implantation failure on live birth per randomized subject as primary endpoint.


Eligibility criteria:
inclusion criteria: * the trial only includes women with a clinical indication for art with a history of rif defined as the absence of implantation after two consecutive cycles of ivf, icsi or frozen embryo replacement cycles where the cumulative number of transferred embryos was no less than four for cleavage-stage embryos and no less than two for blastocysts, with all embryos being of good quality and of appropriate developmental stage. furthermore, other specific 'rif' investigations were performed and treated if necessary: * normal hysteroscopy * normal karyotype of both parents * coagulation screening (antitrombine ii deficiency, factor viii augmentation, apc resistance, factor v + factor ii augmentation, protein s and c deficiency an homocysteine augmentation) * auto-immune screening (lupus anticoagulant, rheumatoid factor, anti-nuclear antibodies, anti-cardiolipine antibodies and glycoprotein-1-antibodies) exclusion criteria: * • simultaneous participation in another clinical study * untreated and uncontrolled thyroid dysfunction * tumors of the ovary, breast, uterus, pituitary or hypothalamus * abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause * ovarian cysts or enlarged ovaries * malformations of the reproductive organs * moderate or severe hepatic impairment * current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy * patients who undergo preimplantation genetic testing (pgt), fertility preservation or oocyte donation * couples needing tese/mesa material
ablation of perimitral flutter following catheter ablation of atrial fibrillation: impact on outcomes

Conditions: Atrial Fibrillation; Perimitral Flutter

Summary: this prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.

background: in recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (af). it is centered around isolating pulmonary veins (pvs) and its success rate in curing af is very high (56%-85%) (1). however, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (pmfl) being the most common macro-reentrant arrhythmia in context of af ablation (2). these often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original af (3) and warrant the necessity for redo-ablation. this study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (pv) with ablation of additional triggers. study method: a total number of 65 af patients presenting for redo-ablation and pmfl will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (pvi) plus ablation of additional triggers. additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.

Eligibility criteria:
inclusion criteria: * patients with previous af ablation presenting with pmfl and recurrent af * age: 18- 75 years * willingness and ability to give written informed consent * therapeutic inr for at least 4 weeks prior to the procedure exclusion criteria: * reversible causes of af such as pericarditis and hyperthyroidism * documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation * enrollment in another clinical study * any other terminal illness
efficacy and safety study of gs-9450 treatment for 6 months in patients with chronic hepatitis c virus infection

Conditions: HCV Infection

Summary: this is a phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter study investigating the safety, tolerability and efficacy of two oral doses of gs-9450 in adults with chronic hepatitis c virus (hcv). approximately 240 subjects 18-65 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of three treatment groups (80 subjects per treatment group) as follows:gs-9450 10 mg once daily,gs-9450 40 mg once daily, or matching placebo once daily. following randomization, subjects will return within seven business days for a baseline (day 1) visit, at which time study medication will be dispensed and subjects will enter a 26 week treatment phase. during the treatment phase, subjects will receive study drug once daily for 24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug once every other day for one week and then every 3 days for one week. following completion of the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.


Eligibility criteria:
inclusion criteria: * adult subjects, ages 18-65 * chronic hcv infection, defined as having documented hcv infection (antibody or rna positivity) at least 6 months prior to baseline (day 1) with hcv viremia at screening * screening knodell necroinflammatory score \>= 3 based on liver biopsy evaluation (as determined by local pathologist) conducted anytime during the 45-day screening period * alt \> the upper limit of the normal range (uln) but \< 10 x uln at the screening visit * previously failed pegylated interferon-based hcv therapy in combination with ribavirin therapy, or is unable to tolerate or has contraindications to receiving interferon or ribavirin therapy * bmi between 19 and 36 kg/m2 (inclusive) * creatinine clearance \>= 70 ml/min * absolute neutrophil count \>= 1000/mm3 * hemoglobin \> 10 g/dl * have no clinical or laboratory evidence of hepatic decompensation exclusion criteria: * decompensated liver disease * child-pugh grade b or c cirrhosis * evidence of hepatocellular carcinoma * positive urine drug screen for cocaine or amphetamines * infection with hcv genotype 3 * co-infection with hepatitis b virus or human immunodeficiency virus * pancreatitis * recent significant infection or symptoms of infection * autoimmune disorders * any history of seizure * is a public transportation operator (pilot of airplane or ship; air traffic controller; bus, train or subway driver) or operates heavy construction machinery * transplantation * history of malignancy * current excessive alcohol ingestion, averaging \> 3 drinks/day for females and \> 4 drinks/day for males * history of or current binge drinking

Keywords: apoptosis liver inflammation hepatitis c
once versus twice daily iron supplementation in pregnant women

Conditions: Anemia in Pregnancy

Summary: the investigators will randomize women diagnosed with anemia in the mid-trimester of pregnancy to once or twice daily iron supplementation

women defined as having iron deficiency anemia based on a low hemoglobin as defined by the american college of obstetrics and gynecology and a low serum ferritin, in the absence of hemoglobinopathy, will be randomized to ferrous sulfate 325mg po daily or po twice daily.

Eligibility criteria:
inclusion criteria: * singleton gestation * iron deficiency anemia as defined by a hgb of less than 11mg/dl in the first and 3rd trimester and 10.5mg/dl in the 2nd trimester and a serum ferritin of less than 15ug/ml. * in accordance with american college of obstetricians and gynecologists (acog) guidelines, the hgb cutoff will be reduced by 0.8mg/dl in african american women. * in accordance with the standard of care, african american women and those with a mean corpuscular volume (mcv) on their routine screening complete blood count (cbc) of less than 70 will require a hemoglobin electrophoresis to exclude hemoglobinopathy prior to enrollment. exclusion criteria: * multiple gestation * maternal hemoglobinopathy or hemochromatosis, * irritable bowel disease or irritable bowel syndrome * history of bariatric surgery or extensive bowel surgery * individuals already receiving iron supplementation aside from prenatal vitamins.
a study to implement and evaluate reflect communication curriculum for oncology based medical graduate students

Conditions: Medical Trainees in Oncology Programs

Summary: the purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. the information that is gathered from this study will be used to describe this population that participate in the workshop and see whether or not introduction of a communication curriculum alongside with the training program will improve communication, self-awareness, and interpersonal skills over time.


Eligibility criteria:
inclusion criteria: * subjects: resident or fellow enrolled in an oncology related training program (radiation oncology, medical oncology, palliative medicine and hospice care, neurooncology). * location: mayo clinic arizona. * interest: willingness to participate. exclusion criteria: * schedule does not permit to participation. * not enrolled in an oncology-based residency or fellowship at mayo clinic arizona. * interest: not willing to participate.
best timing of insulin bolus before meals of different contents

Conditions: Type 1 Diabetes Mellitus

Summary: post-meal glucose excursions may contribute to the development of diabetes-related complications. these glucose excursions are affected by the food content of the meal and the timing of insulin injection (or insulin pump-bolus) before meal. the best timing for insulin bolus (by pump) is controversial. the aim of the study is to examine three different timings of insulin bolus in three types of breakfast meals that contain carbohydrates, carbohydrates + proteins and carbohydrate+ fat. the 3h post-meal glucose excursions will be recorded by continuous glucose monitoring system. the results obtained in the diabetic patients will be compared to those obtained in a group of healthy individuals that will consume similar meals.


Eligibility criteria:
inclusion criteria: diabetes patients: * type 1 diabetes * age 8 to 20 years * both genders control group: * age 18 to 30 years * both genders exclusion criteria: diabetes patients: * less than a year from the diagnosis of type 1 diabetes * less than 6 months from the time of insulin pump introduction control group: * pregnancy * any diagnosed or suspected chronic diseases * current or recent (within 1 month) use of drugs (not including oral contraceptives and inhaled steroids for asthma).

Keywords: insulin bolus glucose excursions post-prandial timing meal content
nature-based solutions for work-related stress

Conditions: Stress, Psychological

Summary: although exposure to nature has restorative effects on human health, beneficial effects of nature-based interventions in the working environment have been underexplored. the investigators aim to conduct a randomised controlled pilot study. during workhours one group participates in a nature-based program, the other group is a control group. the investigators test stress-related parameters including cortisol levels, wellbeing and stress, and neurocognition.

participants of the intervention group follow a 30-minute stress management course in nature followed by a nature-based activity of 1.5 hours, twice a week for 3 consecutive weeks. the investigators measure neurocognition via neurocognitive tests, emotional status via burnout assessment tool and well-being questionnaires, and asses stress levels via salivary cortisol and smartwatches.

Eligibility criteria:
inclusion criteria: * work at province of limburg speak dutch exclusion criteria: -
sample collection study to evaluate dna markers in subjects with inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Disease; Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer

Summary: the primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (ibd) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the exact ibd-acrn surveillance test for colorectal cancer (crc).


Eligibility criteria:
inclusion criteria: * male or female 18 - 84 years of age, inclusive, who have been diagnosed with ibd. * willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia. * written informed consent document signed and dated by the subject. exclusion criteria: * any condition that in the opinion of the investigator should preclude participation in the study. * a history of aerodigestive tract cancer. * prior colorectal resection, except ileocolic resection in crohn's disease patients. * ibd limited only to the rectum. * subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.

Keywords: inflammatory bowel disease cancer colorectal cancer neoplasm colorectal neoplasm intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms digestive system diseases gastrointestinal diseases colonic diseases intestinal diseases rectal diseases
the correlation between renal injury and biomarkers in pediatric ureteropelvic junction obstruction patients

Conditions: Ureteropelvic Junction Obstruction

Summary: urinary neutrophil gelatinase associated lipocalin (ngal) has been recently reported to be related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction (upjo) patients. we are trying to analyze whether it is related with the grade of renal injury in upjo patients.


Eligibility criteria:
inclusion criteria: \ 1. 0-3 year old patients with sfu grade 2 or more hydronephrosis without ureteral dilatation 2. needs pyeloplasty due to differential renal function (drf)\ 1. 0-3 year old patients with sfu grade 3 or 4 hydronephrosis without ureteral dilatation 2. doesn't meet the above criteria for the indication of pyeloplasty \ 1. 0-3 year old children without any abnormality of urinary tract exclusion criteria: \ 1. patients with contralateral disease affecting drf 2. history of previous urinary tract surgery 3. follow up loss before diuretic renogram performed at 6-12 months from operation \ 1. patients with contralateral disease affecting drf 2. history of previous urinary tract surgery

Keywords: hydronephrosis biopsy biomarker
randomized clinical trial of polyester vs. polyurethane patch for carotid endarterectomy

Conditions: Carotid Artery Thrombosis; Carotid Artery Stenosis; Stroke

Summary: this study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. this study was run at the university of roma, la sapienza and at the university of poitiers, randomisation was done in both enters after approval by the ethical committee of the university of roma (record uploaded)

this study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. 598 patients were considered for randomisation between january 1995 and january 2004. the following patients were excluded for randomisation (redo carotid surgery: n=34, radiation induced carotid stenosis:n=45, indication for carotid bypass: n=65, refusal of randomisation: n=4). in total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch. all patients were operated under general anaesthesia and all received an intraoperative angiography. a shunt was selectively used in patients with a recent stroke (\<15 days) or with a contralateral carotid occlusion

Eligibility criteria:
inclusion criteria: * carotid stenosis \> 60% nascet criteria exclusion criteria: * redo carotid surgery * radiation induced carotid stenosis * extensive carotid lesion \> 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass